Delivery system with balloon catheter

ABSTRACT

An intraluminal grafting system includes a hollow graft which has a proximal staple positioned proximate its proximal end and a distal staple adapted proximate its distal end. The system includes a capsule for transporting the graft through the lumen and for positioning the proximal end of the graft upstream in a lumen which may be a blood vessel or artery. A tube is connected to the capsule and extends to exterior the vessel for manipulation by the user. A catheter is positioned within the tube to extend from the cavity and through the graft to exterior the body. The catheter has an inflatable membrane or balloon proximate the distal end thereof which is in communication via a channel with inflation and deflation means located exterior the vessel. With the inflatable membrane deflated, the capsule is positioned in the lumen and manipulated to a desired location. The inflatable membrane is manipulated by the rod away from the graft. The force exerted by the inflatable membrane and the structure of the staples urges the staples in the vessel wall, retaining the graft in position. The remainder of the intraluminal grafting system is then removed from the corporeal vessel.

RELATED APPLICATIONS

This application is a continuation of application Ser. No. 09/405,965,filed Sep. 27, 1999, which is a continuation of application Ser. No.08/748,637, filed Nov. 13, 1996, which is a continuation of applicationSer. No. 08/342,438, filed Nov. 18, 1994, now U.S. Pat. No. 5,662,700,which is a continuation of application Ser. No. 08/175,491, filed Dec.29, 1993, now U.S. Pat. No. 5,397,345, which is a continuation ofapplication Ser. No. 08/034,587, filed Mar. 22, 1993, now abandoned,which is a continuation of application Ser. No. 07/752,058, filed Aug.29, 1991, now abandoned, which is a divisional of application Ser. No.07/166,093, filed Mar. 9, 1988, now U.S. Pat. No. 5,104,399.

BACKGROUND OF THE INVENTION

1. Field

This invention relates to a medical prosthesis and, more particularly,to a graft prosthesis for placement within in a corporeal lumen, such asthe lumen of a blood vessel or artery.

2. State of the Art

Various fluid conducting body lumens, such as veins and arteries, maydeteriorate or suffer trauma so that repair is necessary. For example,various types of aneurysms or other deteriorative diseases may affectthe ability of the lumen to conduct fluids and in turn may belife-threatening. In some cases, the damaged lumen is repairable onlywith the use of prosthesis such as an artificial vessel or graft.

For repair of vital vessels such as the aorta, surgical repair issignificantly life-threatening. Surgical techniques employed involvemajor surgery in which an artificial section of vessel is spliced intothe diseased or obstructed lumen. That is, the damaged or diseasedportion of the lumen may be surgically removed or bypassed and anartificial or donor graft inserted and stitched to the ends of thevessel which were created by the removal of the diseased portion. KajJohansen, Aneurysms, Scientific American, 247:110-125, July 1982. Avariation of the typical suturing technique is described by Albert W.Krause, et al., Early Experience with Intraluminal Graft Prosthesis,American Journal of Surgery, 145:619-622, May 1983. The deviceillustrated in U.S. Pat. No. 3,908,662 to Razgulov, et al. is an exampleof a device to be used in such a surgical procedure.

Other devices for the repair of lumens or vessels such as veins andarteries include a nitinol coil with a graft. The nitinol coil isreduced in dimension when cool. When placed in the body its temperatureincreases, and it returns to a preselected dimension to hold a graftwithin the lumen of the vessel. Such devices are discussed in detail inCharles T. Dottner, et al., Transluminal Expandable Nitinol Coil StentGrafting: Preliminary Report, Radiology 147:259-260, April 1983, andAndrew Cragg, et al., Nonsurgical Placement of Arterial Endoprostheses:A New Technique Using Nitinol Wire, Radiology 147:261-263, April 1983.The use of devices such as the previously discussed nitinol wire may notbe desirable due to the danger of penetrating and damaging the vessel'swall during the emplacement process.

U.S. Pat. No. 4,140,126 to Choudhury discloses a device for intraluminalrepair of an aneurysm. This device is positioned in a vessel in acollapsed form and then hooked into the vessel with hooks that aremechanically extended by the user. This device is mechanically complexand in turn is susceptible to mechanical failure.

Other intraluminal devices are known, for uses other than the repair ofa diseased lumen or vessel. U.S. Pat. No. 3,874,388 to King, et al.discloses a system for closing off a septal defect or shunt in theintravascular system in the myocardial area. U.S. Pat. No. 3,334,629 toCohn discloses a device for restricting the flow of blood. U.S. Pat. No.4,056,854 to Boretus, et al. teaches construction and placement of anartificial aortic heart valve. U.S. Pat. No. 3,834,394 to Hunter et al.teaches construction of an intraluminal device to occlude a bloodvessel. U.S. Pat. No. 3,540,431 to Mobin-Uddin teaches construction ofan umbrella-like filter for intraluminal use. MEDI-TECH, Inc. ofWatertown, Mass. sells a device known as the GREENFIELD Vena Cava filterfor intraluminal placement. U.S. Pat. No. 3,938,528 discloses a devicethat is implanted into the vas-deferens or similar lumen for thesplicing of the lumen parts.

None of the devices noted above disclose a reliable and quick means ormethod to repair a vessel intraluminally.

SUMMARY OF THE INVENTION

An artificial intraluminal prosthesis for placement in a fluidconducting corporeal lumen has a hollow graft of preselectedcross-section and length. The proximal end of the graft is placedupstream within the lumen. The graft is deformable to conformsubstantially to the interior surface of the lumen. Staples are attachedto the proximal end and preferably to the distal end of the graft forstapling the graft to the wall of the lumen.

Each staple has wall engaging members. The wall engaging members of theproximal staple are generally angulated in a downstream direction andhave tips for engaging the vessel wall. The wall engaging members of thedistal staple are angulated in a direction generally perpendicular tothe longitudinal or central axis of the graft, and also have tips forengaging the wall.

Generally, the staples are formed into a V-shaped lattice or framework.In an alternative embodiment, the staples' framework is U-shaped orsinusoidal. The frame of the staples allows for radial deformationresulting in a spring-like effect when a compressed staple is allowed toexpand within a vessel and to sustain itself in that expanded condition.

Preferably, the graft is made of a material suitable for permanentplacement in the body such as nylon or dacron. Prior to emplacement, thegraft is formed to be substantially cylindrical in shape and formed tohave a plurality of substantially evenly placed circumferential bifoldsalong the length thereof. An optional radio-opaque seam on the exteriorof the graft may run along the longitudinal axis of the graft in orderfor the user to observe graft placement through fluoroscopy or by x-ray.

The system for intraluminally engrafting the hollow graft has placementmeans for emplacing the graft into the lumen and positioning it at apreselected position. The placement means includes a capsule shaped andsized for positioning within the lumen. A hollow tube extends from thecapsule to exterior the vessel for manipulation by the user. The graftis retained within the capsule for positioning the graft in the lumen.The placement means includes operation means for removing the graft fromthe capsule and for subsequently urging the staples into the wall of thelumen.

Preferably, the operation means includes a catheter slidably positionedwithin the hollow tube to extend from the capsule to exterior the lumen.The catheter desirably has an inflatable membrane operable by means forinflating and deflating the membrane. Pusher means is attached to thecatheter and sized for passing through the capsule and for urging thehollow graft with attached staples out of the capsule through anupstream or front end aperture.

After the proximal portion of the graft is removed from the capsule, theinflatable membrane is desirably moved to within the circumference ofthe proximal staple and inflated to urge wall engaging members of theproximal staple into the wall.

The balloon is then deflated, and the replacement means manipulated toremove the remainder of the graft from the capsule, thus exposing thedistal staple. Preferably, the distal staple is placed and affixed in amanner similar to the proximal staple.

The placement means is then removed from the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which illustrate the best mode presently contemplatedfor carrying out the invention,

FIG. 1 is a partially cut-away perspective view of an intraluminal graftsystem of the instant invention;

FIG. 2 is a perspective view of a slightly bent graft device of theinstant invention;

FIG. 3 is an enlarged view of a proximal staple of the instantinvention;

FIG. 4 is an enlarged view of a distal staple of the instant invention;

FIG. 5 is an enlarged side view of a capsule of the instant invention;

FIGS. 6, 6A and 7 are cross-sectional views of the intraluminal graftdevice and placement means of the instant invention showing anintraluminal graft being emplaced into a lumen;

FIG. 8 is a perspective exploded view of an alternate embodiment of thecapsule;

FIG. 8A is a partial perspective view of an alternate capsule;

FIG. 9 is an enlarged view of an alternate embodiment of a proximalstaple of the instant invention;

FIG. 10 is an enlarged view of an alternate embodiment of a distalstaple of the instant invention; and

FIG. 11 is an enlarged partial view of an alternate embodiment of astaple of the instant invention.

DESCRIPTION OF THE ILLUSTRATED EMBODIMENT

FIG. 1 illustrates a system 11 for intraluminally placing a prosthesisin a fluid conducting corporeal lumen. The system 11 includes a hollowgraft 12 of preselected cross-section and length. The graft 12, as morefully shown in FIG. 2, has a proximal end 14 for placement upstreamwithin a lumen such as a blood vessel. A proximal staple or anchoringelement 16 is positioned proximate the proximal end 14 of the graft 12and is here shown with portions extending through the graft 12 forstapling the graft 12 through the interior wall 13 of the graft 12 intothe wall of the lumen. A distal staple or anchoring element 17 ispositioned proximate the distal end 88 of the graft 12 and is here shownwith portions extending through the graft 12 for stapling the graft 12to the interior wall 13 of the graft 12 into the wall of the lumen.

The system 11 (FIG. 1) includes placement means for inserting the graft12 into the lumen and for positioning the graft 12 at a preselectedposition within the lumen. The placement means includes a capsule 18which has a front 20 and a back 22. A tube 26 is affixed to the back 22of the capsule 18 and sized in length 25 to extend exterior the body formanipulation by the user. That is, the tube 26 can be manipulated tomove the capsule 18. The placement means also includes operation means,as more fully discussed hereinafter and a wire guide 24.

The capsule 18 is sized for positioning in the lumen. As can be seen inFIGS. 1, 6 and 8, the capsule is hollow and is also sized in length 21and cross section 23 to contain the graft 12 for transport through thelumen.

The operation means preferably includes a hollow catheter 27 slidablypositionable over the wire guide 24. The catheter 27 has an inflatablemembrane (“balloon”) 30 positioned proximate the front end 29 of thecatheter 27. Means to operate the membrane 30 between inflated anddeflated conditions include a channel 34 formed in the wall of catheter27 to be in fluid communication between the interior of the inflatablemembrane 30 and a syringe 38. The channel 34 extends along the length 28of the catheter 27 to the syringe 38 or other means to insert and removefluid to inflate and deflate the membrane 30.

A pusher means here shown as a cylindrically shaped button 31 is affixedto and surrounds the catheter 27. It is placed on the catheter 27 behindor downstream of the membrane 30 as best seen in FIGS. 1 And 6. Thebutton 31 is sized to engage the graft 12 with staples within thecapsule 18 for urging the graft 12 with staples out of the capsule 18 asmore fully discussed hereinafter.

As seen in FIG. 1, syringe mechanism 38 is connected through a connector40 via an extension tube 42 to the channel 34. Those skilled in the artwill recognize that the catheter 27 with the channel 34 and inflatablemembrane 30 are very similar in both structure and function to a balloondilation catheter. It should also be recognized that the syringe ispreferably a conventional syringe having a sleeve 44 within which a handactuated piston 46 is sealably and slidably movable in an inwardly andoutwardly direction 48 to insert a fluid via the tube 42 and channel 34to the membrane 30 to respectively inflate and deflate the membrane 30.The fluid inserted to inflate may be an air or saline solution or suchother fluid as desired by the user. Of course the fluid may be extractedto deflate the membrane 30 by operating the piston 46 in an outwarddirection 48.

The artificial graft 12, shown in FIG. 2, is preferably made of adeformable material having a high tissue ingrowth rate. Various dacron,nylon and teflon materials as well as various polymer materials areregarded as suitable. At present the desired material has been found tobe Plasma TFE made by Atrium Medical Corp. of Clinton Drive, Hollis,N.H. (03049).

The graft 12 is preferably formed to have a plurality of substantiallyevenly spaced circumferential bifolds 50 (similar to the bifolds of abifold door) along its length 52. The bifolds 50 facilitate both axial54 and radial 56 deformation of the graft 12. Therefore, when emplaced,the graft 12 may readily conform to the interior shape of the lumen. Thelength 52 of the graft 12 is selected by the user. Typically, the length52 of the graft 12 will be selected to be longer than the portion of thelumen to be repaired. The radial 56 or cross-sectional size of the graft12 is also selected by the user typically to conform substantially to,or be slightly larger than, the interior cross-section of the involvedlumen. Since the graft 12 is made of a deformable material with bifolds,it can readily be collapsed or squeezed into the capsule 18.

As shown in FIG. 2, two staples or “securing rings” 16 and 17 arepositioned about the circumference of the substantially cylindricallyshaped graft 12. Preferred staples are shown in FIGS. 3, 4, 9 and 10.

The staples 16 and 17 are collapsible from an initial diameter to asecond smaller diameter. The initial diameter of the staples will begenerally the same as the diameters 56 of the graft 12 and the same asor slightly larger than that of the lumen into which the graft 12 withstaples 16 and 17 is to be placed. The second diameter will be the sameor slightly smaller than inside diameter of the capsule 18. Also, thestaples 16 and 17 will generally be made of a metal suitable for use inthe body or biocompatible plastic. A stainless steel wire material ispresently preferred because of its excellent spring characteristics. Asbest seen in FIG. 2, the staples 16 and 17 are positioned within thegraft 12 and may even be stitched thereto. The staples 16 and 17 aresized to urge the graft 12 outwardly against the inside surface of thelumen into which the graft 12 is placed.

In one embodiment, the proximal staple 16 (FIG. 3) has a plurality ofV-shaped support members 60. Each V-shaped support member 60 has an apex62 with two “free ends” or legs, for example 60A, 60B, 60C and 60D. Afree end 61A abuts and is adjoined to the free end 61B of anotherV-shaped support member 60 at an abutment point 63. The plurality of atleast three V-shaped support members 60 are each connected one toanother in a generally circular arrangement around the longitudinal axis67 as shown. With the use of an elastically deformable or springmaterial, it can be seen that the staple of FIG. 3 can be compressed tomake the angle 64 smaller to in turn reduce the staple diameter to fitwithin the capsule 18.

A wall engaging member 70 is attached to each support member 60generally along the length 66 of one of the legs 60A, 60B and preferablyat or proximate each of at least three abutment points 63 of theproximal staple 16. The preferred wall engaging members 70 are barbs orelongated tine-like members with sharp points 71. The wall engagingmembers 70 are attached to the support members at an angle 75 which mayvary from about 15° to about 135 degrees from the longitudinal orcentral axis 67 of the proximal staple 16. Preferably the wall engagingmembers 70 angulate away from the axis 67 in a downstream direction 100(FIG. 6); and thus the angle 75 is preferably less than 90° anddesirably in the range from about 30° to about 60°.

It should be noted that the number or quantity of support members 60 isdetermined by the axial length 66 of the staple as well as by the crosssectional size of the lumen and in turn the capsule 18. FIG. 3 depicts aplurality of six support members 60 which has been found to be suitablefor use in the lumen of selected animals where the lumen is comparablein size to an adult aorta. That is, the lumen has an average oreffective diameter of about 12 to 18 millimeters.

It should also be noted that wall engaging members 70 are used topenetrate and hook into the interior surface of the lumen to hold thegraft 12 in place. Although in some cases two wall engaging members 70may be sufficient, it is preferred that at least three be provided. Ifthe lumen is an artery or vein, some deformation is typicallyexperienced so that actual penetration or hooking may be difficult withonly two and hooking or penetration is facilitated by the use of threeor more. Of course it is most preferred that a wall engaging member beadapted to each support member to facilitate engagement with the walland also to assist in holding the upstream or proximal end of the graft12 more securely against the wall of the lumen to minimize fluid (e.g.,blood) leakage during the post-therapy healing process.

The proximal staple 16 may be unitarily formed, or may be constructed byinterconnecting separate, V-shaped support members having vessel wallengaging members 70. That is, a stainless steel spring wire may be bentto form the apexes 62 and abutment points 63 and soldered or welded at aselected point to be unending as shown. Alternately, separate legs ofsupport members 70 may be welded, glued or soldered together asappropriate to obtain desired strength.

A preferred proximal staple 104 (FIG. 9) is also comprised of aplurality of V-shaped support members 106. Each support member 106 hasan apex 108 and two free ends or legs 110. A leg 110A abuts to and isadjoined to the leg 110B of another V-shaped support member 106A at anabutment point 112. The V-shaped support members 106 are connected oneto another in a generally circular arrangement around the longitudinalaxis 114 to form an unending fence-like arrangement similar to thearrangement of proximal staple 16 (FIG. 3).

In FIG. 9, wall engaging members 116 are adapted to the support members106 at or near at least three abutment points 112 of the proximal staple104. However, in the preferred proximal staple 104, an extension member118 is also mounted to the staple 104 at abutment point 112. Each ofthese extension members 118 may have an optional and additional wallengaging member 120 attached thereto. The wall engaging members 116, 120are all mounted to proximal staple 104 at an angle 122 comparable toangle 75 for staple 16 of FIG. 3. The preferred mounting angle of thevessel wall engaging members 116, 120 is from about 30° to about 60degrees. For ease in insertion into wall of the lumen, wall engagingmembers 116, 120 are all preferably mounted generally at the same angle122. That is, the members 116 and 120 are in reality quite small anddifficult to mount with precision. Thus the angles may vary as much as10 degrees. Further, the extension 118 is used to provide additionalaxial length to the staple 104 without affecting the size of the supportmembers 106 and in turn the second or smaller diameter when collapsedinside capsule 18.

A distal staple 17 (FIG. 4) also preferably comprises a plurality ofV-shaped support members 65. Each V-shaped support member is formed tohave an apex 69, and two free ends or legs 71A and 71B. A free end 71Aabuts and is adjoined to the free end 71B of another V-shaped supportmember 65 at an abutment point 73. The V-shaped support members 65 ofthe distal staple 17 are connected one to another in a generallycircular arrangement similar to the staple shown in FIG. 3. At aplurality of the abutment points 73 wall engaging members 72 areattached generally at an angle 76 preferably perpendicular to thelongitudinal axis 77 of the distal staple. The angle 76 between the wallengaging member 72 and the longitudinal axis 77 may vary between about45 degrees and about 115 degrees. Preferably, the wall engaging members72 of the distal staple are sufficiently short so as not to perforatethe vessel wall.

A preferred distal staple 124 is depicted in FIG. 10. It has a pluralityof V-shaped support members 126 formed with an apex 128 and two freelegs 130A and 130B. A leg 130A abuts and is adjoined to the leg 130B ofan adjacent V-shaped support member 126 at an abutment point 132. TheV-shaped support members 126 of distal staple 124 connect one to anotherin a generally circular arrangement about axis 134 to form a fence-likearrangement similar to the staples shown in FIGS. 3 and 4.

Wall engaging members 136 are mounted at or near at least three abutmentpoints 132 of distal staple 124. Distal staple 124 has extension members138 mounted at a plurality of abutment points 132 with a separate wallengaging member 140 mounted thereto, all similar to that shown forstaple 104 (FIG. 9). As in distal staple 17, the wall engaging members136, 140 are mounted to the staple 124 at an angle which may vary fromabout 45° to about 115°. Preferably the angle varies from about 75degrees to about 105 degrees, and is most desirably generallyperpendicular to axis 134. As in proximal staple 104, both thecorresponding wall engaging members 136, 140 are mounted at the sameangles to the staple 124.

The support members may also be U-shaped, as shown in FIG. 11 for all ofthe aforementioned staples 16, 17, 104 and 126. The arrangement wouldthus appear generally sinusoidal. In another alternative embodiment, thevessel wall engaging members 70, 72, 116, 120, 136 and 140 of FIGS. 3,4, 9 and 10 may be barbed like fish hooks similar to barbed member 139shown in FIG. 11.

Referring now to FIG. 6, portions of the system 11 (FIG. 1) forintraluminal engrafting are shown cross-sectionally within a lumen 90.The system 11 including the graft 12 and capsule 18 may be constructedin a variety of different sizes in order to accommodate and becompatible with a variety of differently sized (in cross-section)corporeal lumens. In FIGS. 6 and 7, the capsule 18 is shown to besmaller than the lumen 90 so that the various surfaces may be betterillustrated. Typically, the cross-sectional size (i.e., area normal toaxis 54) of the pertinent system components such as the capsule 18 andgraft 12 are selected to be substantially the same as or slightlysmaller than the lumen 90. It should be further recognized that thecorporeal lumen 90 illustrated is substantially circular incross-section. However, lumens such as blood vessels may vary widely incross-section along their length but will elastically deform to receivethe capsule 18 and other components of the system 11. The lumens arealso not straight in that they have many curves as they coursethroughout the body.

As shown in FIG. 5, the capsule 18 preferably has a rounded or taperededge surface 92 between the side surface 94 and the front 20. Thetapered surface 92 facilitates entry into and positioning within thelumen 90 by providing a contact surface to stretch the lumen especiallyin those places where the lumen 90 may be constricted or smaller incross-section than the capsule 18 and the graft 12. A corporeal lumensuch as a blood vessel or artery can stretch and deform. The taperedsurface 92 can urge or force the deformation desired in order tofacilitate placement as the capsule 18 is urged into and through thelumen 90 by exerting an emplacing force on the exterior end 96 of thetube 26.

The inside of the capsule 18 has a smooth bore cavity 98 (FIG. 6) formedtherein sized to receive the graft 12. As can be seen, the catheter 27may be centrally positioned within the cavity 98. Lead or guide wire 24may be positioned within the lumen 90 in a manner known in the art andthen threaded through the interior of the catheter 27. The tube 26 isaffixed to the capsule 18 at its back 22 to extend rearwardly ordownstream 100 through an opening 102 made in the lumen for insertingthe pertinent components of the system 11. The catheter 27 can slidablymate within the hollow tube 26.

The capsule 18 as shown in FIG. 5 has an aperture 19 formed in its frontend 20 which is sized for passage of the graft 12 with staples 16 and17. That is, the graft 12 with staples 16 and 17 are urged throughaperture 19 for placement in the lumen 90 as hereinafter discussed. Thecapsule 18 is formed of any medically acceptable material. A variety ofnylon and teflon materials are known to be acceptable along withselected metals. It is here preferred to use stainless steel as thestaples are easier to urge outwardly through the aperture 19. Theconnection means is structured to provide a smooth exterior surface asseen in FIG. 5.

As shown in FIG. 6, the graft 12 is positioned within the cavity 98 ofthe capsule 18. The graft 12 and staples 16 and 17 are preferably sizedas hereinbefore discussed when in an undeformed condition to be slightlylarger in cross-section than the cross-section of the lumen 90 and yetdeformable to fit into the cavity 98. An external or radial force isthereby exerted outwardly against the interior surface 160 of the cavity98 to retain the graft 12 within the capsule 18. Further, the lumenengaging portion of the disclosed staples may frictionally engage theinterior surface 104 of the capsule 18 to further restrain and retainthe graft 12 within the cavity during placement in the lumen.

As shown in FIG. 8, the capsule 18 preferably consists of two connectingtubular portions 152, 89 which mate together by connection means whichare here shown to be a coacting male threaded member 101B and femalethreaded member 101A. Such a construction is used to aid in placing thegraft 12 within the capsule 18 so as to house it within the capsule 18.The proximal portion 89 of the capsule 18 can be disconnected from thedistal portion 152. The distal end 15 of graft 12 is then positionedwithin the distal portion 152 of the capsule 18. The proximal end 14 ofthe graft 12 is similarly positioned into the proximal portion 89 of thecapsule which is then connected to the distal portion 152. The catheter27 is then extended into the capsule and the graft 12. The connectionmeans is preferably selected to minimize the amount of relative rotationbetween the proximal and distal portions 152, 89 to minimize twisting ofthe graft 12.

Whatever the form of the capsule 18, it can be seen in FIG. 6 that anopening 102 is formed in the lumen 90 such as an artery, vessel or othersimilar corporeal lumen. A guide wire 24 may be then sequentiallyinserted therethrough and manipulated to a desired location. Anappropriately sized capsule 18 with graft 12 are inserted through theopening 102 and into the lumen 90 over the guide wire 24. With the graft12 in position as shown in FIG. 6, the capsule 18 is urged in anupstream direction by exerting a positioning force on the exterior 108of tube 26 (FIG. 1). Then the catheter 27 may be inserted. Of course,the guide wires 24, catheter 27, and tube 26 are each sized to be ofsufficient length 25 and 28 so that the capsule 18 and graft 12 may bepositioned through the lumen 90 to a desired position which may be somedistance from the entry point 102. It will also be recognized by thoseskilled in the art that appropriate radiological techniques such asfluoroscopy can be used to assist the user in positioning the capsule 18and in turn the graft 12 at a precise desired position within the lumen90. This position, in all likelihood, would be a diseased or damagedportion of the lumen 90 which is in need of repair. Upon reaching thedesired position within the lumen 90, further forward or upstreammovement within the lumen 90 is stopped. A clamp or other means may beplaced about the catheter 27 outside the vessel to prevent movement ofthe catheter 27 relative to the tube 26. The tube 26 may also be securedor held by the user as desired.

The pusher button 31 and catheter 27 are then used to urge the graftforwardly or upstream through the aperture 19. The proximal end 14 ofthe graft 12 first leaves the capsule 18 as the pusher button engagesportions of the distal end of the compressed proximal staple 16. Forpurposes of this illustration staples 16 and 17 (FIGS. 3 and 4) will beused. However, staples 104 and 124 could be substituted in their placeas could any other equivalent staple. The pusher button 31 has adiameter small enough to fit through the tube 26 and into the graft 12and through aperture 19 of the capsule 18. The catheter 27 is maintainedin a steady position while the tube 26 is moved downstream from theproximal staple 16. The balloon 30 may be inflated as shown in FIG. 6Ato provide a holding force and resist relative movement as to the lumen90. The pusher button 31 makes contact with pieces of the compressedproximal staple 16 urging the proximal staple through the aperture 19 ofthe capsule 18.

As the proximal staple 16 is pushed through the aperture 19 of thecapsule 18 it springs open or expands, causing the wall engaging members70 to contact with the wall of the lumen 90. After the proximal staple16 has been completely removed from the capsule 18 and the wall engagingmembers 70 have made initial contact with the wall, the inflatablemembrane 30 is moved to within the circumference of proximal staple 16and graft 12. The inflatable membrane (“balloon”) 30 is then inflated(see FIG. 7) by use of the inflation means 36 to urge the wall engagingmembers 70 into the wall surface of the lumen 90 to firmly lodge theproximal staple 16 and the graft 12 in place.

The capsule 18 is then moved downstream 100 even more to free the distalportion 15 of the graft 12 from the capsule 18 and exposing the distalstaple 17 and wall engaging members 72 to the interior surface of thelumen 90. The balloon 30 may be deflated, moved to register with thestaple 16 and inflated to ensure that the graft 12 remains securelypositioned. After the distal portion 15 is free, the balloon 30 isdeflated and moved to register with the distal staple 17. The balloon 30is then reinflated to urge the wall engaging members 72 of the distalstaple 17 into the wall thereby firmly securing the distal staple 17 anddistal end 15 of the graft to the lumen 90. An angiogram may then beperformed if desired through the balloon catheter to determine thepatency and security of the graft 12. Other balloon catheters may beused which do not have the main lumen to perform the angiogram. Thus,the guide wire is not then used and a separate angiogram catheter neededto perform a subsequent angiogram.

The balloon 30 is then deflated and the tube 26 with capsule 18 iswithdrawn from within the lumen 90. After removing the tube 26 in itsentirety, the catheter 27 is thereafter removed and the opening 102sealed. The back 22 of the capsule 18 may be formed to have a slightlyrounded edge 89A to facilitate removal as shown in FIG. 8A.

After emplacement, it can be seen that the pressure of the lumen fluid,for example, blood, forces the graft 12 against the lumen interiorsurface 154, helping to hold the graft 12 in place. The bifolds 50 ofthe graft 12 permit deformation of the graft 12 to conform to theinterior surface 154 of the lumen and provide for flexibility to bendand stretch with the natural lumen. Further, the bifolds 50 act somewhatas a mechanical labyrinth seal to reduce leakage between the interiorsurface 154 of the lumen and the exterior surface 84 of the graft 12.That is, the internal pressure of the fluid within the lumen 90 holdsthe graft 12 in place and assists the staples 16 and 17 in preventingleakage at both ends of the graft 12.

In operation, it should be noted that the system 11 with the graft 12 isinserted into the lumen 90 using accepted surgical techniques. Forexample, an opening could be made through the leg to reach the mainartery of a human being. Thereafter, the system 11 could be used asabove described to emplace an artificial graft within the main artery asfar interior the body as the myocardial or great artery area. Thistechnique therefore avoids major surgery in which the chest or abdomenis penetrated for repair of the aorta, vena cava or the like.

The components of system 11 are, of course, made of anatomicallycompatible substances. For example, the tube 26 and inflatable membrane30 are made of a substantially chemically compatible plastic. Thecatheter 27 is made of a material such as Teflon to be flexible andsized in appropriate diameter and length to facilitate placement of thegraft 12 in the desired location within the lumen 90.

Use of the system 11 with the graft 12 herein described may preclude theneed for major surgery to repair a vessel, such as a blood vessel orartery in the great artery area. It can also be used to repair othervessels or ductiles within the body of a human being or animal. Use ofthe system may thus reduce the morbidity rates associated with majorsurgery. It also facilitates rapid repair of defective or damagedvessels at relatively low cost and risk. The system is mechanicallysimple and reliable and also useful for treating trauma victims in anemergency context.

It may be noted that the system 17 herein described, including the graft12, are merely illustrative of the application of the principles of theinvention. Reference herein to details of the illustrated embodiments isnot intended to limit the scope of those claims which themselves recitethose features regarded as essential to the invention.

I claim:
 1. A system for placement within vasculature, comprising: agraft having a front end; an elongate catheter; and a balloon catheter,said balloon catheter having an inflatable portion; wherein saidinflatable portion is positioned entirely beyond said front end of saidgraft when said system is configured for insertion into vasculature. 2.The system of claim 1, said elongate catheter further comprising acapsule, said capsule being dimensioned to receive said graft.
 3. Thesystem of claim 1, said elongate catheter further comprising a tubewhich slidably receives a portion of said balloon catheter.
 4. Thesystem of claim 1, wherein said graft is a graft assembly.
 5. The systemof claim 4, said graft assembly further comprising a tubular body and atleast one attachment system.
 6. The system of claim 5, wherein saidattachment system embodies a plurality of V-shaped support membersconnected together in a circular arrangement.
 7. The system of claim 6,said attachment system further comprising at least one wall engagingmember attached to one of said V-shaped members.
 8. The system of claim1, the elongate catheter including structure that encapsulates thegraft.
 9. The system of claim 1, the elongate catheter further includesan exit port, said exit port being positioned at a front end of thecatheter.